Details for New Drug Application (NDA): 212995
✉ Email this page to a colleague
The generic ingredient in DEFERASIROX is deferasirox. There are twenty drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the deferasirox profile page.
Summary for 212995
Tradename: | DEFERASIROX |
Applicant: | Piramal Hlthcare Uk |
Ingredient: | deferasirox |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 212995
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DEFERASIROX | deferasirox | TABLET;ORAL | 212995 | ANDA | Xiromed, LLC | 70700-269 | 70700-269-30 | 30 TABLET in 1 BOTTLE, PLASTIC (70700-269-30) |
DEFERASIROX | deferasirox | TABLET;ORAL | 212995 | ANDA | Xiromed, LLC | 70700-270 | 70700-270-30 | 30 TABLET in 1 BOTTLE, PLASTIC (70700-270-30) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 90MG | ||||
Approval Date: | Dec 30, 2019 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 360MG | ||||
Approval Date: | Dec 30, 2019 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 180MG | ||||
Approval Date: | Jun 15, 2020 | TE: | AB | RLD: | No |
Complete Access Available with Subscription